ACE RECONSTRUCTIVE PLATE— 510(k) K905595

Substantially Equivalent

Ace Medical Co.

FDA 510(k) clearance K905595 for ACE RECONSTRUCTIVE PLATE, Substantially Equivalent on 1991-03-14. Applicant: Ace Medical Co..

Clearance details

Applicant: Ace Medical Co.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 1990-12-13
Decision date: 1991-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.